Megatrend International · 89-08 · KOREA (THE REPUBLIC OF)
For Megatrend International, import alert is 89-08; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Class II | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses); product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 12/06/2010; address is 207 Seowoo Bldg #497sangdo-1dong , Dongjak-kudongjak-ku, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Megatrend International verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 207 Seowoo Bldg #497sangdo-1dong , Dongjak-kudongjak-ku, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/06/2010 verified
- Product code
- 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort each item verified
- Product
- Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Class II | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) | Contact Lenses (Circle Lenses) each item verified
- FDA notes
- Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II each item verified
What the source says
Megatrend International Date Published : 12/06/2010 207 Seowoo Bldg #497sangdo-1dong , Dongjak-kudongjak-ku, KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 12/06/2010 Desc: Class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 M - - VN Lens, Contact (Disposable) Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 12/06/2010 Desc: Contact Lenses (Circle Lenses) Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html